- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03914521
Pre-surgical CT Scan Assessment of Bone Mineral Density Before Resection of NHO of the Hip
Pre-surgical CT Scan Assessment of Femoral Head Bone Mineral Density Before Resection of Neurogenic Heterotopic Ossification (NHO) of the Hip
Neurogenic heterotopic ossification (NHO) is defined as an ectopic ossification around proximal joints usually seen after traumatic brain injury, spinal cord injury or polytrauma.
NHO causes pain, partial or total joint ankylosis and vascular or nerve complications.
The osteopenia (low bone density) induced by ankylose increases the fracture risk of femoral neck during the hip surgery performed to remove the NHO.
The analyse of femoral head bone mineral density from hip pre-surgical CT scan could anticipate this kind of complication establishing a presurgical prognostic.
If as it turns out the bone density measured from hip pre-surgical CT scan is relevant fracture risk marker, a preventive osteosynthesis or femoral head and neck resection could be performed in the same time of NHO resection.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Montpellier, France, 34295
- UHMontpellier
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients having surgery resection of surgery resection of Neurogenic heterotopic ossification of hip.
Their per-operative CT-scan and surgery report will be collected from the records of Nîmes and Montpellier University Hospital Center
Description
Inclusion Criteria:
- Patients aged 18 years and over
- Patients having surgery resection of surgery resection of Neurogenic heterotopic ossification of hip.
- Patients with pre-surgery CT-scan and surgery report available
Exclusion criteria:
- Minor patients
- Patients didn't have surgery surgery resection of Neurogenic heterotopic ossification of hip.
- Pre-surgery CT-scan and surgery report not available
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
femoral head bone mineral density
Time Frame: 1 year
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femoral head bone mineral density
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Florence BAUMANN, MD, University Hospital, Montpellier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RECHMPL19_0095
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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